- Closing of asset transfer from Otifex Therapeutics
- Rights to additional preclinical and clinical data complement scope of data package
- Initiation of Phase 1 trial of AM-125 planned for the fourth quarter of 2017
ZUG, Switzerland, July 20, 2017 (GLOBE NEWSWIRE) -- Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important, unmet medical needs in otolaryngology, today announced that it has completed its acquisition of various assets related to intranasal betahistine from Otifex Therapeutics Ltd. The assets, which comprise preclinical and clinical data as well as intellectual property rights, have been fully transferred to Auris Medical with the closing of the transaction. They form the basis for the development of AM-125, an intranasal formulation of betahistine for the treatment of Meniere's disease and other vestibular disorders. In addition to the Otifex transaction, Auris Medical obtained from an undisclosed party the right to use certain proprietary preclinical and clinical data that will support the AM-125 development program and future regulatory filings.
"We are pleased to have efficiently assembled a package of relevant data to support the development of intranasal betahistine, a program with the potential to deliver significant clinical benefits to patients with vestibular disorders," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "Next, we plan to discuss the development strategy with U.S. and European regulatory agencies, with the goal of initiating the second Phase 1 trial of AM-125 in the fourth quarter of this year. We are targeting a U.S. investigational new drug (IND) submission in the first quarter of 2018 and would expect to proceed to a Phase 2 proof-of-concept trial following regulatory clearance."
In a previous Phase 1 trial, intranasal betahistine demonstrated good tolerance and significantly higher blood plasma concentrations when compared to data reported with oral betahistine. In addition, a 14-day study in beagle dogs demonstrated that intranasal delivery was well tolerated with repeated dosing. The second Phase 1 clinical trial of AM-125 is planned to evaluate single- and multiple-ascending doses in healthy subjects. The study will determine the maximum tolerated dose following intranasal administration and assess pharmacokinetics in blood plasma. The study outcomes will inform dose selection and regimen for a subsequent Phase 2 proof-of-concept trial.
About Meniere's Disease and Vertigo
Meniere's disease is a chronic disorder of the inner ear characterized by episodes of vertigo (sensation of feeling off balance), ringing in the ears (tinnitus), hearing loss, and fullness in the ear. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 American adults currently diagnosed with Meniere's disease and no therapies are currently approved by the U.S. Food and Drug Administration. Vertigo refers to symptoms resulting from dysfunction within the body's system of balance, including the misperception of movement or dizziness. Data from the U.S. National Health and Nutrition Examination Survey suggest that as many as 69 million American adults have experienced some form of vestibular disorder.
 Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults. Arch Intern Med. 2009;169(10):938-944.
About AM-125 (intranasal betahistine) for Vestibular Disorders
Auris Medical is developing AM-125, an intranasal formulation of betahistine, for the treatment of Meniere's disease and other vestibular disorders. Betahistine is a small molecule drug that acts as a histamine H1-receptor agonist and a H3-receptor antagonist, approved for use by oral administration in more than 115 countries worldwide. The compound has demonstrated the ability to increase cochlear, vestibular and cerebral blood flow, improve vestibular compensation and the ability to inhibit neuronal firing in the vestibular nuclei. Intranasal delivery of AM-125 is intended to bypass the effects of first-pass metabolism found with oral delivery of betahistine, potentially offering benefits in efficacy and tolerability. In a Phase 1 trial, intranasal betahistine demonstrated good tolerance and significantly higher plasma concentrations in comparison with oral betahistine. In Meniere's disease, the objective of treatment with AM-125 is the treatment or prevention of vertigo attacks. In the case of vertigo, the objective is to restore balance.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology. The company is focused on the Phase 3 development of treatments for acute inner ear hearing loss (AM-111) and for acute inner ear tinnitus (Keyzilen®; AM-101) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is developing intranasal betahistine for Meniere's disease and vestibular vertigo (AM-125) as well as early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical's product candidates, including the likelihood that the TACTT3 clinical trial with Keyzilen® will not meet its endpoints, the acceptability of the data from AMPACT1 and AMPACT2 in support of a potential new drug application to the FDA and other regulators, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings; the use of proceeds from Auris Medical's recent equity offering and the ability of Auris Medical to finance its operations in the future. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
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